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IRCT20190130042555N2 IRCT 2026-05-21 Hamedan University of Medical Sciences Comparison the effects of active distraction and Shen Men point massage on pain and anxiety during venipuncture in children 4-7 year old Comparison the effects of active distraction and Shen Men point massage on pain and anxiety during venipuncture in children 4-7 year old hospitalized 2026-05-20 anticipated 144 Complete https://irct.ir/trial/88962 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling and Randomization Initially, all hospitalized children aged 4–7 years who met the inclusion criteria were stratified based on age (4–5 years and 6–7 years) and gender (female/male) in order to balance the distribution of these potential confounding variables across the study groups. Within each stratum, a list of eligible children was prepared, and a unique numerical code was assigned to each child. For randomization, a random allocation list for the three groups (active distraction group, Shen Men point massage group, and control group) was prepared in advance by an individual independent of the sampling process using a random numbers table (or computer‑generated random numbers). In this list, the allocation sequence of participants to the three groups was arranged using random blocks of equal size (e.g., blocks of six) to ensure that the number of participants in each group remained approximately equal. When each eligible child entered the study, the researcher responsible for data collection assigned the participant to one of the three groups according to the predetermined allocation sequence and the order of enrollment, without any personal judgment or interference. In this way, the likelihood of allocation bias was minimized and the principle of randomization was maintained in the study, Blinding description: The study will be single-blind, meaning that the statistician will not know the type of intervention in the groups. N/A Pain. Intervention 1: intervention Group:In the active distraction group, after providing an introduction, explaining the study objectives, and obtaining informed consent from the parents and the child, the child—accompanied by the mother—is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and free of additional stimuli). First, the Piyeri Anxiety Scale is completed by an assessor.Three semi-prepared cartoon animal templates (such as lion, rabbit, and elephant), designed based on psychological principles of visual attractiveness, along with accessories such as stickers, child-safe scissors, and colored pencils, are provided to the mother and child. They are given 5 minutes to collaboratively complete and personalize the chosen figure. The researcher actively assists the mother and child during this stage.The completed figure is then gently attached to the IV catheter cover to serve as an engaging visual element. The cover, now decorated with the figure, is handed to the child to hold and interact with during venipuncture.Immediately afterward, venipuncture is performed by a trained and experienced nurse who has not previously met the child during hospitalization and has been instructed to maintain consistent behavior with all participants. During catheter insertion, pain intensity is assessed using the Wong-Baker Visual Analog Scale, and anxiety levels are assessed using the Facial Anxiety Scale by an independent assessor who has been previously trained in scoring and evaluation.Immediately after venipuncture, the Piyeri Anxiety Scale is administered again and recorded by the assessor. Finally, the decorated figure is placed on the IV dressing after the procedure is completed. Intervention 2: Intervention Group: Acupressure GroupAfter introducing the study, explaining its objectives, and obtaining informed consent from the parents and the child to participate in the research, the child, accompanied by the mother, is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and free from additional stimuli). First, the Piyeri Anxiety Scale is measured by the assessor.In the presence of the mother, Shen Men point massage is performed by the researcher on the hand opposite to the venipuncture site for five minutes. The massage procedure is conducted as follows: the child lies on the bed, the researcher first washes and warms their hands, then stands beside the child’s bed, applies baby oil to their hands, and performs circular massage on the Shen Men point in a clockwise direction with moderate pressure.The maximum continuous massage duration is one minute, followed by a ten‑second pause. This cycle continues until the completion of venipuncture. After five minutes from the start of the massage, venipuncture is performed by a trained and experienced nurse who has not previously met the child during hospitalization and has been instructed to maintain consistent behavior during venipuncture with all children.During the insertion of the intravenous catheter, pain intensity is recorded using the Wong–Baker Visual Analog Scale, and anxiety levels are assessed using the Facial Anxiety Scale by an assessor who has been previously trained in the assessment and scoring procedures. Immediately after the completion of venipuncture, the Piyeri Anxiety Scale is measured again by the assessor and recorded. Intervention 3: Control GroupAfter introducing the study, explaining its objectives, and obtaining informed consent from the parents and the child to participate in the research, the child, accompanied by the mother, is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and without additional stimuli). First, the Piyeri Anxiety Scale is administered by the assessor.Children in this group receive only the routine care of the ward. Venipuncture is then performed by the same skilled nurse, who has not previously seen the child during hospitalization and has been trained to maintain consistent behavior during venipuncture with all participants.During insertion of the intravenous catheter, pain intensity is assessed using the Wong–Baker Visual Analog Scale, anxiety is assessed using the Facial Anxiety Scale, and heart rate is recorded by an assessor who has been previously trained in assessment and scoring procedures. Immediately after completion of the venipuncture, the Piyeri Anxiety Scale is administered again by the assessor and recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Taybeh Hassan Tehrani
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Pazhohesh Square, Hamadan, Iran
Hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3838 0150 t.tehrani@umsha.ac.ir Hamedan University of Medical Sciences scientific Taybeh Hassan Tehrani
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Pazhohesh Square, Hamadan, Iran
Hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3838 0150 t.tehrani@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Hospitalized child 4 to 7 years old (48 to 83 months) Having healthy organs and skin in the hand Do not use painkillers for at least 3 hours before venipuncture. The child's first hospitalization Second experience of venipuncture during hospitalization Has not had a traumatic venipuncture and has only had one previous successful venipuncture Have informed consent to undergo the procedure At least 24 hours have passed since the child was hospitalized. 4 years 7 years Both Failure to obtain a vein the first time Aggravation of the child's condition G89.1 Acute pain, not elsewhere classified Prevention Prevention Other intervention Group:In the active distraction group, after providing an introduction, explaining the study objectives, and obtaining informed consent from the parents and the child, the child—accompanied by the mother—is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and free of additional stimuli). First, the Piyeri Anxiety Scale is completed by an assessor.Three semi-prepared cartoon animal templates (such as lion, rabbit, and elephant), designed based on psychological principles of visual attractiveness, along with accessories such as stickers, child-safe scissors, and colored pencils, are provided to the mother and child. They are given 5 minutes to collaboratively complete and personalize the chosen figure. The researcher actively assists the mother and child during this stage.The completed figure is then gently attached to the IV catheter cover to serve as an engaging visual element. The cover, now decorated with the figure, is handed to the child to hold and interact with during venipuncture.Immediately afterward, venipuncture is performed by a trained and experienced nurse who has not previously met the child during hospitalization and has been instructed to maintain consistent behavior with all participants. During catheter insertion, pain intensity is assessed using the Wong-Baker Visual Analog Scale, and anxiety levels are assessed using the Facial Anxiety Scale by an independent assessor who has been previously trained in scoring and evaluation.Immediately after venipuncture, the Piyeri Anxiety Scale is administered again and recorded by the assessor. Finally, the decorated figure is placed on the IV dressing after the procedure is completed. Intervention Group: Acupressure GroupAfter introducing the study, explaining its objectives, and obtaining informed consent from the parents and the child to participate in the research, the child, accompanied by the mother, is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and free from additional stimuli). First, the Piyeri Anxiety Scale is measured by the assessor.In the presence of the mother, Shen Men point massage is performed by the researcher on the hand opposite to the venipuncture site for five minutes. The massage procedure is conducted as follows: the child lies on the bed, the researcher first washes and warms their hands, then stands beside the child’s bed, applies baby oil to their hands, and performs circular massage on the Shen Men point in a clockwise direction with moderate pressure.The maximum continuous massage duration is one minute, followed by a ten‑second pause. This cycle continues until the completion of venipuncture. After five minutes from the start of the massage, venipuncture is performed by a trained and experienced nurse who has not previously met the child during hospitalization and has been instructed to maintain consistent behavior during venipuncture with all children.During the insertion of the intravenous catheter, pain intensity is recorded using the Wong–Baker Visual Analog Scale, and anxiety levels are assessed using the Facial Anxiety Scale by an assessor who has been previously trained in the assessment and scoring procedures. Immediately after the completion of venipuncture, the Piyeri Anxiety Scale is measured again by the assessor and recorded. Control GroupAfter introducing the study, explaining its objectives, and obtaining informed consent from the parents and the child to participate in the research, the child, accompanied by the mother, is taken to the venipuncture room. The room environment is standardized and calming (with soft lighting and without additional stimuli). First, the Piyeri Anxiety Scale is administered by the assessor.Children in this group receive only the routine care of the ward. Venipuncture is then performed by the same skilled nurse, who has not previously seen the child during hospitalization and has been trained to maintain consistent behavior during venipuncture with all participants.During insertion of the intravenous catheter, pain intensity is assessed using the Wong–Baker Visual Analog Scale, anxiety is assessed using the Facial Anxiety Scale, and heart rate is recorded by an assessor who has been previously trained in assessment and scoring procedures. Immediately after completion of the venipuncture, the Piyeri Anxiety Scale is administered again by the assessor and recorded. The effect of active distraction on pain intensity. Timepoint: During venipuncture. Method of measurement: Wang Baker Facial Scale. The effect of Shen Men point massage on pain intensity. Timepoint: During venipuncture. Method of measurement: Wang Baker Facial Scale. The Impact of Shen Men Point Massage on Anxiety Levels. Timepoint: Before, during, and after venipuncture. Method of measurement: Piyeri Anxiety Visual Scale. The Impact of Active Distraction on Anxiety Levels. Timepoint: Before, during, and after venipuncture. Method of measurement: Piyeri Anxiety Visual Scale. Hamedan University of Medical Sciences Approved 2026-01-24 Research Ethics Committee of Hamadan University of Medical Scieneces Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Pazhohesh Square, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)